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| |  Ketoconazole 2% Foam Effective and Safe for Seborrheic Dermatitis: Presented at AAD By Bruce Sylvester SAN ANTONIO, TX -- Feb. 5, 2008 -- Ketoconazole 2% foam treatment is effective and safe, and is suitable for treatment of patients 12 years or older with seborrheic dermatitis (SD), researchers reported here at the American Academy of Dermatology 66th Annual Meeting (AAD). The findings from a phase 3 clinical trial were reported at a poster session on February 4. "Significantly more subjects obtained treatment success with ketoconazole foam compared to [placebo]," said presenter and investigator William Abramovits, MD, Professor of Dermatology, Baylor University Medical Center, Dallas, Texas, United States. "The side effects of ketoconazole treatment were very insignificant." Dr. Abramovits and colleagues compared the safety and efficacy of ketoconazole (2%) in a hydroethanolic formulation foam vehicle to the vehicle foam alone for patients with mild to severe SD. In their phase 3, multicentre, double-blind trial, the investigators enrolled 847 subjects aged 12 years or older diagnosed with mild to severe SD. They randomised 427 patients to 4 weeks of treatment with ketoconazole 2% foam and 420 to the vehicle foam, both treatments administered twice daily on the head, face, or trunk. The primary efficacy endpoint was the proportion of subjects achieving "treatment success," which is an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 for scaling, erythema, and induration at week 4. A secondary endpoint was the proportion of subjects who had modified treatment success at week 4, defined as a ISGA score of 0 or 1, an erythema score of 0 (normal) or 1 (faint) at the target area, and a scaling score of 0 (normal) or 1 (minimal) at the target area, with at least 2 grades of improvement for each parameter. Adverse events were recorded at each study visit. Investigators evaluated each subject at baseline (day 1), week 2, and week 4. All endpoints were analysed using an intent-to-treat analysis. The researchers reported that significantly more subjects achieved treatment success using ketoconazole foam versus vehicle foam (56% vs. 42%, respectively; P <.0001), and efficacy was similar across age, gender, race, and baseline disease severity. They also found that the proportion of subjects achieving modified treatment success was significantly higher for the ketoconazole foam group (50%) than for the vehicle foam group (33%; P <.0001). Ketoconazole foam was safe and well tolerated. Most common adverse events were mild, transient burning at the application site and mild reactions at the application site. There was no statistically significant difference in the incidence of adverse events between the ketoconazole cohort and the vehicle/placebo cohort. (P =.8075). The authors concluded, "Ketoconazole 2% foam, the first available antifungal foam formulation for the treatment of mild to severe SD, is effective, safe, and suitable for patients with SD on the head, face, or trunk, regardless of age, gender, race, and baseline disease." The US Food and Drug Administration approved ketoconazole 2% foam on July 26, 2007 for the topical treatment of SD in patients aged 12 years or older. Funding for this study was provided by Stiefel Laboratories, Inc.
[Presentation title: Ketoconazole 2% Foam in the Treatment of Mild to Severe Seborrheic Dermatitis. Poster 1703]
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